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angiojet ultra avx thrombectomy set
Possis Medical
Summary: The AngioJet Ultra AVX Thrombectomy Set is a medical device used for mechanical thrombectomy in venous systems. It is typically utilized by interventional radiologists and vascular surgeons to remove thrombi from blood vessels.
FDA Clearance Information
Pathway
510K
Number
K133629 ↗
Decision Date
February 14, 2014
Product Code
QEW
Device Class
Class 2
Evidence
0 studies
The AngioJet Ultra AVX Thrombectomy Set was cleared through the FDA 510(k) pathway on February 14, 2014. Manufactured by Possis Medical, it is a Class 2 device under product code QEW.
What It Is
The AngioJet Ultra AVX Thrombectomy Set is a mechanical thrombectomy device designed to remove thrombi from veins. It operates using high-speed saline jets to create a vacuum effect that breaks up and removes blood clots. This device is particularly useful in restoring blood flow in patients with venous thromboembolism.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is employed in procedures to treat deep vein thrombosis (DVT) and other venous thromboembolic conditions. The AngioJet system is particularly beneficial for patients who are contraindicated for anticoagulation therapy or require rapid clot removal.
Indications for Use
The FDA indications for the AngioJet Ultra AVX Thrombectomy Set include the mechanical removal of thrombi from venous systems. It is intended for patients with conditions like deep vein thrombosis, where clot removal is necessary to restore proper blood flow.
Practical Considerations
The AngioJet system is available in various sizes to accommodate different vessel diameters. It is compatible with standard catheterization techniques and requires careful handling to ensure effective clot removal. Clinicians should be trained in its use to optimize outcomes.
Frequently Asked Questions
What is the AngioJet Ultra AVX Thrombectomy Set used for?
It is used for the mechanical removal of thrombi from venous systems, particularly in cases of deep vein thrombosis.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is cleared for the mechanical removal of thrombi from venous systems.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.